AHPA, GMA ask FDA for facility registration guidance

AHPA, GMA ask FDA for facility registration guidance

AHPA joined Grocery Manufacturers Association and 19 trade organizations representing the food industry in submitting a letter to request prompt release of FDA's Guidance for Industry regarding the food facility registration renewal process.

The American Herbal Products Association (AHPA) on Sept. 21 joined the Grocery Manufacturers Association (GMA) and 19 trade organizations that represent the food industry in submitting a letter to the Food and Drug Administration (FDA) to request prompt release of FDA's Guidance for Industry regarding the food facility registration renewal process.

The FDA Food Safety Modernization Act (FSMA) amended registration requirements for food facilities so that the former one-time registration process has now been replaced by a requirement to renew registrations between Oct. 1 and Dec. 31 of each even-numbered year starting in 2012.

The groups' letter to FDA states that the food industry "needs guidance to understand both the logistical and substantive requirements for re-registration" and notes that it would be "extremely inefficient and costly for companies to re-register shortly after Oct. 1 based on the old procedures, only to find out later they have to do it all over again after FDA clarifies the new procedures in its new guidance." The letter states that "it will be difficult, if not impossible, for food facilities to effectively and efficiently meet FSMA's registration renewal mandate without guidance from FDA."

"Every AHPA member that operates any facility where foods, including dietary supplements, are manufactured, processed, packaged, or held, will be required to register with FDA in the next three months," said Michael McGuffin, AHPA president. "We are extremely grateful to GMA for initiating this important communication to FDA, and we are pleased to join in this request for timely guidance."

As reported in an AHPA Update on Sept. 18, AHPA submitted separate comments to FDA on Sept. 14 to make numerous specific suggestions regarding FDA's recently published guidance, also authorized by FSMA, on new food categories that will be required to be disclosed when facilities complete their registrations.

"FSMA represents the most significant revision to the Federal Food, Drug, and Cosmetic Act in over 70 years," added McGuffin. "AHPA will maintain active attention on its ongoing implementation."

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